Fecal dysfunction
Conditions
Interventions
OAB trial group:Electrical stimulation of the tibial nerve
OAB control group:Electrical stimulation of the tibial nerve
UAB trial group:Intravesical electrical stimulation
UAB control group:Intravesical electrical stimulation
Sponsors
Beijing Bo'ai Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Wireless Bluetooth mobile phone APP program-controlled tibial nerve stimulator test: (1) Age 60-75 years old (including boundary value), gender is not limited; (2) Excessive bladder activity in accordance with the "2019 Chinese Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases". diagnostic criteria; (3) agree to receive wearable percutaneous tibial nerve stimulation system (TTNS) therapy; (4) Voluntarily participate in this clinical trial and sign the informed consent form; (5) Unsatisfactory efficacy of taking ß3 agonists or anticholinergic drugs, or due to taking anticholinergics Patients who are intolerant of adverse reactions produced by drugs, or who are unwilling to take oral drugs; (6) The voiding diary (3 days before randomization) showed an average of 8 urination times per 24 hours = He who; (7) If you intend to take ß3 agonists or anticholinergic drugs during the study period, you need to be in Discontinuation of anticholinergic drugs for = 7 days prior to the screening period. If you intend to continue taking beta3 agonists for the duration of the study or For anticholinergic drugs, the dosage should be kept unchanged until the test is completed. (8) Able to communicate well with the investigator and be willing to comply with the requirements of the whole trial. 2) Micro portable intelligent intravesical electrical stimulator test: (1) Age 60-75 years old (including boundary value), gender is not limited; (2) Patients who have been diagnosed with UAB and whose disease duration is more than 3 months; (3) Previous routine intermittent catheterization to empty the bladder, or with intermittent catheterization indications (residual urine volume functional bladder capacity of more than 40%); (4) Those who voluntarily signed a written informed consent form; (5) Able to communicate well with the investigator and willing to comply with the requirements of the whole trial.
Exclusion criteria
Exclusion criteria: 1) Wireless Bluetooth mobile phone APP program-controlled tibial nerve stimulator test: (1) Those who install a pacemaker (the impact of electrical stimulation on the safety of the pacemaker); (2) Patients with uncontrolled symptomatic urinary tract infection, bladder tumor, and urinary calculus; (3) Hydronephrosis combined with clinical symptoms of lumbar distension or low back pain on the opposite side, and the serum creatinine > 1.2 times normal Patients with upper limit of values; (4) Epilepsy patients, senile dementia, cerebral atrophy, acute phase of cerebrovascular disease, cognitive impairment , Parkinson's, patients with complete spinal cord injury; (5) Those with mental disorders who cannot cooperate with doctors; (6) Skin lesions at the treatment site that cannot be stimulated; (7) The presence of malignant tumors and other concomitant diseases that seriously affect health; (8) Able to communicate well with the investigator and be willing to comply with the requirements of the whole trial. 2) Micro portable intelligent intravesical electrical stimulator test: (1) Age 60-75 years old (including boundary value), gender is not limited; (2) Patients who have been diagnosed with UAB and whose disease duration is more than 3 months; (3) Previous routine intermittent catheterization to empty the bladder, or with intermittent catheterization indications (residual urine volume functional bladder capacity of more than 40%); (4) Those who voluntarily signed a written informed consent form; (5) Able to communicate well with the investigator and willing to comply with the requirements of the whole trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual urine volume;Change in voiding frequency from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wexner constipation score;Efficiency of bladder emptying;Maximum urine flow rate;Software display automatically;The proportion of patients who were completely removed from intermittent catheterization;Frequency of intermittent catheterization;PPBC-S score;NBD score;Number of nocturnal urination;AUA-SI-QOL score;AUA-SI score;NBD-score;Wexner constipation score;Cleveland incontinence score;The incidence of adverse events;Average volume of urine output per session;Times of urgency to urinate;Number of urinary incontinence;PPBC-S;AUA-SI score;QOL score; | — |
Countries
China
Contacts
Public ContactLimin Liao
Beijing Bo'ai Hospital
Outcome results
None listed